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Monoclonal Antibodies

Guselkumab for Psoriatic Arthritis (SOLSTICE Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 112 weeks
Awards & highlights

SOLSTICE Trial Summary

This trial will evaluate whether the drug guselkumab is effective in treating psoriatic arthritis in people who have not responded well to other treatments.

Who is the study for?
This trial is for people with active psoriatic arthritis who haven't responded well to or can't tolerate a previous anti-TNF alpha treatment. They should have had PsA for at least 6 months, meet specific criteria, and show certain symptoms like swollen/tender joints and elevated CRP levels.Check my eligibility
What is being tested?
The study tests the effectiveness of guselkumab in reducing symptoms of PsA compared to a placebo in those who didn’t respond to prior TNF blockers. Participants will be randomly assigned to receive either guselkumab or a placebo.See study design
What are the potential side effects?
Potential side effects of guselkumab may include reactions at the injection site, upper respiratory infections, headache, fatigue, digestive issues, and possibly serious infections due to immune system suppression.

SOLSTICE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PsA affecting my fingers, many joints, or spine with joint pain.
Select...
I have PsA and didn't respond well to my first TNF alpha blocker treatment.

SOLSTICE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 112 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 112 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
Secondary outcome measures
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score at Week 24
Change From Baseline in HAQ-DI Score at Week 24
+15 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Upper respiratory tract infection
1%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up
Ixekizumab
Guselkumab

SOLSTICE Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3: Placebo Followed by GuselkumabExperimental Treatment2 Interventions
Participants will receive placebo SC and will cross over to receive guselkumab SC.
Group II: Group 2: GuselkumabExperimental Treatment1 Intervention
Participants will receive guselkumab SC.
Group III: Group 1: Guselkumab and PlaceboExperimental Treatment2 Interventions
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5970
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,383,840 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,459 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04936308 — Phase 3
Condition Research Study Groups: Group 1: Guselkumab and Placebo, Group 3: Placebo Followed by Guselkumab, Group 2: Guselkumab
Condition Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT04936308 — Phase 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04936308 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this kind of experiment been done before?

"As of now, there are 21 ongoing clinical trials for Guselkumab in 282 different cities and 57 countries. The first trial was completed in 2018 by Janssen Research & Development, LLC. A total of 1406 patients were involved and the study reached Phase 2 & 3 during the drug approval process. In the years since 2018, 18303 more trials have been carried out."

Answered by AI

What have researchers found in terms of the safety of Guselkumab?

"There is some evidence that Guselkumab is effective and multiple rounds of data collected thus far support its safety; we rate it a 3."

Answered by AI

How many people are currently enrolled in this study?

"That is correct, the clinical trial was posted on September 28th, 2021 and is actively searching for patients. The most recent update to the information was made on October 6th, 2022. They are looking for a total of 450 participants from 53 different locations."

Answered by AI

Where can people go to participate in this clinical trial?

"The 53 active clinical trial sites for this study are geographically dispersed, with The Woodlands, Huntington Beach and Birmingham being a few of the many locations. To reduce travel burden, patients are encouraged to enroll at the nearest site."

Answered by AI

Can you tell me if Guselkumab has been researched before?

"There are currently 21 trials involving Guselkumab, with 7 in Phase 3. Many of these studies originate from Milan and Kansas, but there are 2682 clinical trial locations for Guselkumab globally."

Answered by AI

Is this study still looking for more participants?

"Yes, this is an ongoing trial that is still looking for enrollees. According to the information on clinicaltrials.gov, the data was originally posted on September 28th, 2021 and updated as recently as October 6th, 2022. There are 450 spots available at 53 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
New York
New Jersey
How old are they?
18 - 65
What site did they apply to?
Arthritis Rheumatic And Back Disease Associates
DJL Clinical Research, PLLC
Johns Hopkins University
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
~180 spots leftby Dec 2025